Quality Engineer Jobs

About The Position

Requirements

• Bachelor's degree in Engineering.
• At least 3 years of related experience in Manufacturing/Quality Engineering and/or Quality Systems.
• At least 3 years of experience working in an ISO-certified environment.
• Experience in the medical device industry or another regulated industry.
• Ability to travel to local supplier sites up to 10%.
• Ability to complete tasks on time with minimal supervision and identify potential risks.

Nice To Haves

• ASQ certification.
• FDA Quality Management System Regulation (QMSR) certification or familiarity with QMSR/GMP regulations.
• Knowledge of TrackWise, Windchill PLM, Grand Avenue, or similar systems.
• Experience with supplier controls, supplier audits, or supplier monitoring.
• Knowledge of ISO 13485 regulations.

Responsibilities

• Participate on cross-functional new product development teams, focusing on product and service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, design experiments, capability studies, statistical process control (SPC), and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Update or establish documented work instructions as needed.
• Review collected data, perform statistical analysis, and recommend process or product changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and company facilities on quality-related issues.
• Support evaluation and disposition of nonconforming materials to maintain product integrity and quality.
• Perform quality system audits and provide guidance on corrective actions.
• Share technical knowledge, identify technical problems, and provide innovative solutions.
• Generate detailed, high-quality technical documentation to capture and communicate designs.
• Complete tasks on time with minimal supervision while identifying potential risks.
• Drive process improvements for better efficiency and use advanced tools and best practices to track product and process metrics.
• Mentor team members on timely task completion and participate in brainstorming sessions.
• Perform other duties as assigned.

Benefits

• Market-competitive pay and bonus participation.
• Extensive paid time off and additional holidays.
• Healthcare, dental, and vision benefits.
• Long- and short-term disability coverage.
• 401(k) with company match.
• Maternity and paternity leave.
• Pet insurance and other add-on benefits or discounts.
• Tuition reimbursement and continuing education programs.
• Opportunities for advancement in a stable, long-term career.